Medical University Of Vienna
Vienna, Austria
Not recruitingSplenectomy
Study on the Safety and Immune Response of Meningococcal B Vaccine in Adults Without a Spleen
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What is this trial about?
A plain-language summary of the goals, design and what participants do
This clinical trial is focused on studying the effects of a vaccine called Bexsero in adults who have had their spleen removed, a condition known as asplenia. The vaccine is designed to protect against a type of bacteria called Neisseria meningitidis group B, which can cause serious infections. The study aims to see if the vaccine works as well in people without a spleen as it does in healthy individuals.
Participants in the study will receive the Bexsero vaccine through an injection into the muscle. The study will involve two vaccinations, and the main focus is to measure the body's immune response one month after the second vaccination. This will be done by checking the levels of protective antibodies in the blood. The study will also look at how long these antibodies last and will monitor any side effects that may occur after receiving the vaccine.
The goal of the study is to ensure that the vaccine provides adequate protection for people with asplenia, as they are at a higher risk for infections. The study will compare the immune response of these individuals to that of healthy people to determine if the vaccine is equally effective in both groups. Participants will be observed for any adverse events, and their immune response will be assessed through various tests.
The research process
The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
4 criteria
- Must have **asplenia**, which means not having a working spleen, either because it was removed (**splenectomy**) or it doesn't function properly.
- Must be between **18 to 60 years of age**.
- If you are a female, you must have a **negative urine pregnancy test** at the start of the study and agree to use **adequate birth control** during the study.
- Must provide **written informed consent**, which means you agree to participate in the study after understanding all the details.
Who cannot join the trial?
1 criterion
- Patients who have had a splenectomy cannot participate. A splenectomy is a surgery to remove the spleen, an organ that helps fight infections.
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Investigated drugs
BEXSERO® is a vaccine designed to protect against infections caused by a type of bacteria known as meningococcal serogroup B. This vaccine works by helping your body build its own defense system, known as the immune system, to fight off these bacteria. In this clinical trial, the vaccine is being tested to see how well it works in people who do not have a spleen, compared to those who do. The spleen is an organ that helps fight infections, so people without a spleen may have a different response to the vaccine. The goal is to ensure that the vaccine is just as effective in these patients as it is in healthy individuals.
- Outer Membrane Vesicles (Omv) From Neisseria Meningitidis Group B Strain Nz98/254 Measured As Amount Of Total Protein Containing The Pora P1.4 Adsorbed On Aluminium Hydroxide
- Recombinant Neisseria Meningitidis Group B Fhbp Fusion Protein Produced In E. Coli Cells By Recombinant Dna Technology Adsorbed On Aluminium Hydroxide
- Recombinant Neisseria Meningitidis Group B Nada Protein Produced In E. Coli Cells By Recombinant Dna Technology Adsorbed On Aluminium Hydroxide
- Recombinant Neisseria Meningitidis Group B Nhba Fusion Protein Produced In E. Coli Cells By Recombinant Dna Technology Adsorbed On Aluminium Hydroxide
What is already known about the treatment
BEXSERO® – BEXSERO® is a vaccine administered through an injection, typically given in the upper arm. It is currently being studied for its effectiveness and safety in patients who have had their spleen removed, a condition known as asplenia. The main purpose of this vaccine is to protect against infections caused by meningococcal serogroup B bacteria. It works by stimulating the body's immune system to produce antibodies that can recognize and fight off these bacteria. BEXSERO® is classified as a meningococcal vaccine and is designed to help prevent serious bacterial infections.
Investigated diseases
Splenectomy – Splenectomy is not a disease but a surgical procedure involving the removal of the spleen. The spleen is an organ that plays a role in filtering blood and supporting the immune system. After the spleen is removed, the body may become more susceptible to infections, as the spleen helps fight certain bacteria. The absence of the spleen can lead to changes in blood cell counts, particularly affecting red blood cells and platelets. Over time, other organs, such as the liver, may partially compensate for the loss of the spleen's functions. Patients who have undergone splenectomy may require vaccinations and other preventive measures to reduce the risk of infections.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-508192-36-00Protocol codeMenB_AspleniaEstimated enrolment80 patientsSponsorMedical University Of Vienna
sourced from the EU Clinical Trials Register and site verification
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